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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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FDA Rescinds Alkermes Refuse to File Letter

Alkermes on Monday announced that the US Food and Drug Administration (FDA) has reversed an earlier decision to issue a refuse to file (RTF) letter and accepted for review a new drug application (NDA) for the company’s experimental treatment for major depressive disorder.

“FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued March 30, 2018 follows productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission. No additional data or analyses were submitted by Alkermes to FDA,” the company said in a statement Monday.

CEO Richard Pops said in an investor call on Monday that FDA made the decision to reverse the RTF on Friday, saying the letter was inconsistent with the content of the NDA, and whereas “facial deficiencies,” such as “missing information or clear inadequacies” are usually the cause of RTF letters, this letter was issued based on insufficient evidence, and “did not reflect a complete understanding” of Alkermes’ submission. FDA also said there was a lack of an adequate bridging strategy, which Alkermes said was explained to the agency earlier, according to Pops.

The comments follow Alkermes’ press release from earlier this month in which it said FDA “has taken the position that it is unable to complete a substantive review of the regulatory package, based on insufficient evidence of overall effectiveness for the proposed indication, and that additional well-controlled clinical trials are needed prior to the resubmission of the NDA.”

But whether the initial RTF letter was issued because of a question of the experimental treatment's effectiveness, as Alkermes’ take on FDA’s position says, remains to be known, as the public only hears industry’s side.

Draft guidance from FDA released in December 2017 on such RTF letters notes the increase in “administrative complexity of applications, with corresponding complexity in determinations of application completeness.”

But examples of deficiencies leading to RTF letters in the draft mostly center on administrative issues, such as information that’s lacking in the NDA or applications that are inadequately organized. The draft guidance remains vague on whether “evidence of overall effectiveness” can be assessed that early in FDA’s process.

The draft also notes that, if after an informal conference, an applicant requests that the review division file the application (with or without amendments to correct the deficiencies), the review division will file the application over protest.

An Alkermes spokesperson said the company "did not file under protest or refile the submission."

"We were hopeful that these differences could be resolved following conversations with FDA. We promptly reached out to FDA after receipt of the refusal to file letter," the spokesperson said. "They quickly engaged, we had productive dialogue, and FDA took action Friday evening with the formal acceptance of the NDA."

A look back at past RTF letters also reveals that RTF letters do not necessarily predict whether an application will receive approval or be rejected. Many of the medical product applications the receive an RTF end up winning approval at a later date.